Implementing the EU HTA Regulation in Italy: a multi-stakeholder perspective from the Mogliano Veneto Working Group

Regulation (EU) 2021/2282 on health technology assessment (HTA), hereafter the HTA Regulation (HTAR), entered into application on January 12, 2025, and has introduced a new framework for Joint Clinical Assessments (JCAs) and Joint Scientific Consultations (JSCs) at the European level. In Italy, this transition raises immediate methodological, organizational and relational questions for the Italian Medicines Agency (AIFA), health technology developers (HTDs), scientific societies, patient associations and civic organizations. This Point of View summarizes the perspective developed by Working Group 3 (WG3) during the 8th Edition of the Mogliano Veneto Seminars (25-26 September 2025), dedicated to the implementation of the HTAR in Italy. WG3 identified methodological heterogeneity in early assessment scope definition, limited formal interaction between national stakeholders, and the absence of an operational national HTA scientific advice as the main practical issues emerging in the first phase of implementation. Five practical recommendations were developed: reactivation of National HTA Scientific Advice; more structured AIFA-HTD interaction in view of national pricing and reimbursement; better alignment between regulatory and HTA pathways from the start of the European Medicines Agency (EMA) procedure through the Member States (MS) scoping input to the assessment scope; capacity building and support for the participation of Italian scientific societies and patient associations in HTAR-related activities; and systematic use of European capacity-building opportunities. The recommendations do not imply legislative reform. Rather, they point to the need for coordinated implementation, clearer interfaces between European and national levels, and better use of existing institutional and scientific capacities.